Early Administration of Lactose-free Milk in Children Presenting With Acute Diarrhea

NCT ID: NCT01269892

Last Updated: 2011-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-08-31

Brief Summary

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The purpose of this study is to determine which nutritional regime is better for acute diarrhea in outcomes.

Detailed Description

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Diarrhea is still the most important cause of mortality and morbidity in children of the developing countries. We evaluated the effectiveness of early administration of lactose free milk in the management of acute diarrhea in children below two years old.

Conditions

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Acute Diarrhea

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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lactose-free milk

it is kind of nutritional regime

Group Type OTHER

lactose-free milk

Intervention Type DIETARY_SUPPLEMENT

a milk without lactose

conventional milk

it is kind of nutritional regime

Group Type OTHER

conventional milk

Intervention Type DIETARY_SUPPLEMENT

a milk with lactose

Interventions

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lactose-free milk

a milk without lactose

Intervention Type DIETARY_SUPPLEMENT

conventional milk

a milk with lactose

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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nothing nothing

Eligibility Criteria

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Inclusion Criteria

1. children with acute non-bloody diarrhea (≤ 2 weeks)
2. mild to moderate dehydration

Exclusion Criteria

1. mucous bloody stools
2. major systemic illness
3. severe malnutrition (Weight for age \<60% and Weight for height \<70 %)
4. history of antibiotics receiving
Minimum Eligible Age

3 Months

Maximum Eligible Age

14 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Isfahan University of Medical Sciences

Principal Investigators

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Ali Gholamrezaei, MD

Role: STUDY_CHAIR

MD,research comittee

Locations

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Al-zahra university hospital

Isfahan, Isfahan, Iran

Site Status

Countries

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Iran

Other Identifiers

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ASD-1213-9

Identifier Type: -

Identifier Source: org_study_id

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